BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCHITECT STAT HIGH SENSITIVE TROPONIN-I

    MDR report key: 25298844 · Received May 27, 2026

    Report

    Report Number
    3005094123-2026-00251
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Date of Event
    May 18, 2026
    Report Date
    May 27, 2026
    Manufacturer
    ABBOTT IRELAND DIAGNOSTICS DIVISION
    Product Code
    MMI
    UDI-DI
    00380740165093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION A PATIENT INFORMATION: REFER TO SECTION B5 FOR COMPLETE PATIENT INFORMATION. AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE. THIS REPORT IS BEING FILED ON AN INTERNATIONAL PRODUCT, LIST NUMBER 3P25 (TROPONIN-I, STAT HIGH SENSITIVE) THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US, LIST NUMBER 2R98 (TROPONIN-I STAT HIGH SENSITIVITY) WITH 510K/PMA/BLA NUMBER K191595. ALL AVAILABLE PATIENT INFORMATION WAS INCLUDED. ADDITIONAL PATIENT DETAILS ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER OBSERVED FALSE ELEVATED ARCHITECT STAT HIGH SENSITIVE TROPONIN-I RESULTS GENERATED ON THE I2000SR PROCESSING MODULE FOR TWO PATIENT SAMPLES. THE FOLLOWING RESULTS WERE PROVIDED: (CUSTOMER PROVIDED REFERENCE RANGE LESS THAN 0.0262 UG/L) SID (B)(6) INITIAL RESULT = 26.804 UG/L, REPEAT RESULT = 0.001 UG/L SID (B)(6) INITIAL RESULT = 26.804 UG/L, REPEAT RESULT = 0.001 UG/L NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    483859 ARCHITECT STAT HIGH SENSITIVE TROPONIN-I IMMUNOASSAY METHOD, TROPONIN SUBUNIT MMI ABBOTT IRELAND DIAGNOSTICS DIVISION 85255UD00 00380740165093

    Patients

    Seq Age Sex Outcome Treatment
    1